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Cepheid Gets CE Mark for Hepatitis C Viral Load Test

NEW YORK (GenomeWeb) – Cepheid said today that it has received a CE IVD mark for Xpert HCV Viral Load, a test that provides quantitative, on-demand confirmation of infection and monitoring of hepatitis C virus.

The test is intended for use as an aid in the management of HCV-infected patients undergoing antiviral therapy. It can be used to measure HCV RNA levels at baseline and during treatment, and to help predict sustained and nonsustained virological responses to HCV therapy. In addition, it can be used to confirm HCV serologic test results.

Xpert HCV Viral Load runs on Cepheid's GeneXpert system, of which there are more than 8,000 deployed worldwide, Cepheid noted.

"Cepheid's Xpert HCV Viral Load test delivers results in hours rather than days — with the simplicity and ease of use of a point-of-care test," Jean-Michel Pawlotsky, professor of medicine at the University of Paris-Est and director of the National Reference Center for Viral Hepatitis B, C, and Delta, said in a statement released by Cepheid. "It is a very sensitive test for confirmation of infection and monitoring of HCV, and will assist in better patient management."

Cepheid CEO John Bishop noted at the JP Morgan Healthcare Conference in January that the company is stepping up its efforts in the area of viral load testing, a particular strength of competitor Roche. In December, Cepheid received CE IVD marking for the Xpert HIV-1 viral load assay and said it expected to receive CE IVD marking for the Xpert HIV Qualitative assay in the first half of this year.